Kornimate/medical-research-clean huggingface dataset:
reliability of point-of-care inr measurements in patients with antiphospholipid-antibody syndrome treated with warfarin

Conditions: Antiphospholipid Syndrome

Summary: the antiphospholipid-antibody syndrome (apla), which includes lupus anticoagulant, anticardiolipin, and anti-beta-2-glycoproteini antibodies, is a thrombophilic disorder associated with arterial thrombosis, venous thrombosis or both. patients diagnosed with apla have a higher risk of recurrent thrombosis than do patients without known antibodies. currently, warfarin is considered the anticoagulant of choice for prophylactic antithrombotic treatment for apla patients after their first episode of thrombosis. in some patients with apla who are treated with warfarin, the inr values determined on plasma are unreliable due to an influence of the apla on the inr. in these individuals, alternative monitoring methods, such as factor ii activity, chromogenic factor x activity or prothrombin-proconvertin time should be used to assess adequate anticoagulation. these tests are expensive and not widely available to some clinicians. point-of-care (poc) instruments, on the other hand, are readily accessible to clinicians. previous research has shown that inr values from 3 older point-of-care (poc) instruments are unreliable in 1/3 of apla patients (coaguchektm, protimetm, inratiotm). however, there are now newer versions of these poc instruments available (coaguchek xstm, an investigational protime device, and a newer inratiotm device) and it is unknown if these newer poc instruments are reliable in patients with apla. the purpose of this study is to determine whether newer poc instruments are reliable in patients with apla.


Eligibility criteria:
apla inclusion criteria: * prolongation of a phospholipid-dependent screening assay, 2) lack of correction of a prolonged screening assay after a 1:1 mix with pooled normal plasma, and 3) correction of a prolonged screening assay by the addition of excess phospholipid. two positive lupus anticoagulant confirmations at least 3 months apart will be required. * diagnosis of anticardiolipin antibodies defined as elevated levels of aca-igg (\>30) and/or aca-igm (\>15) on two separate occasions at least 3 months apart. * stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of inr. apla exclusion criteria: * patients whose warfarin dose has changed within the past 2 weeks. control inclusion criteria: * no evidence of either a positive la or aca diagnosis by confirmation of negative laboratory values and/or documentation of no clinical signs and symptoms concurrent with these conditions. * stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of inr. control exclusion criteria: * patients whose warfarin dose has changed within the past 2 weeks.
montelukast and nasal epithelial cell inflammatory responses in asthma and rhinitis

Conditions: Asthma; Allergic Rhinitis

Summary: the airways of the lung are lined by specialised cells called airway epithelial cells. as well as being at the interface between the lungs and the air we breathe; airway epithelial cell (aec) function is altered in people with respiratory diseases such as asthma. aec secrete many mediators that contribute to asthma symptoms and these also contribute to asthmatic inflammation in the lungs. the study of such cells is difficult because of their location deep in the lungs. nasal airway epithelial cells provide a useful and easily accessible model of model of lower airway cells. this study will examine whether the asthma medication singulair (montelukast) can inhibit the inflammatory secretions of nasal aec of asthmatic patents who also have allergic rhinitis compared with patients who have asthma alone. we will also examine if montelukast has differential modulating effects in these two patient groups.

hypothesis the inflammatory secretory profile of nasal airway epithelial cells (nec) cultured from asthmatics with concomitant allergic rhinitis (ar) will differ from that of nec from patients with asthma alone. treatment (in vitro and in vivo) with montelukast may have differential modulating effects in these two patient groups. for the primary objective of this proposal we will use nasal aec from asthmatics with or without concomitant ar as to ascertain differences in pro-inflammatory cytokine and chemokine production between these two groups and determine whether in vitro treatment with montelukast has a differential modulating effect on nec secretion. in the secondary pilot study any modulating effects by montelukast on aec secretion in vitro will be correlated with any in vivo response to montelukast withdrawal. this sub study will provide pilot data indicating whether in vivo response to montelukast can be predicted from in vitro effects on nec.

Eligibility criteria:
inclusion criteria: * stable physician confirmed mild/moderate asthma (steps 1-4 of bts/sign guidelines \<10 pack-year smoking histories currently taking montelukast with a documented clinical history of benefit exclusion criteria: * nasal corticosteroid therapy

Keywords: montelukast asthma allergic rhinitis nasal epithelial cells inflammatory mediators
study of the use of luma lightwire

Conditions: Sinusitis

Summary: this pilot study will evaluate the accuracy and ease of use of the luma light wire and whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon dilation procedures.

50 patients undergoing functional endoscopic with balloon dilatation sinus surgery will be studied using the light wire technology. this will be used as a guide for the surgeon to know when they are safely in the sinus by trans-illumination through the sinus wall prior to utilizing balloon dilation. routine fluoroscopy will be used as well to verify the position of the wire, which is currently standard practice. the ease, time required, and accuracy of placement will be recorded for each case and compared to data previously collected when suing standard wire technology.

Eligibility criteria:
inclusion criteria: * patients needing endoscopic sinus surgery * initial or previous sinus surgery subject will be included exclusion criteria:

Keywords: sinusitis
high fiber rye foods for weight and body fat reduction

Conditions: Overweight; Obesity

Summary: the overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypocaloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention. furthermore the study will investigate the effect on appetite as a potential underlying mechanism for differences in weight loss and body fat reduction.


Eligibility criteria:
inclusion criteria: * bmi 27-35 kg/m2 * hb≥120g/l * serum thyroid stimulating hormone (tsh) ≤4.00 miu/l * plasma low density lipoprotein cholesterol \<5.3 mmol/l * plasma triglycerides ≤1.8 mmol/l * signed informed consent * freezer capacity for 2 weeks bread provision exclusion criteria: * blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study * unable to complete satisfactorily the 3-day weighted food record at screening visit 2. * unable to lose 0.5 kg or more during the run-in period for men and women not having menstruation during the run in period * increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period. * using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.) * using e-cigarettes (regardless of nicotine content) * following any weight reduction program or having followed one during the last 6 months prior to visit 1 * diastolic blood pressure 105 mm hg at visit 1 * systolic blood pressure 160 mm at visit 1 * history of stomach or gastrointestinal conditions (inflammatory bowel disease, crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.) * more than 10 hours physical activity per week * history of heart failure or heart attack within 1 year prior to screening * have type i diabetes * receiving pharmacological treatment for type ii diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol) * previous gastrointestinal surgery * thyroid disorder * history of drug or alcohol abuse * stroke or transient ischemic attack (tia) within 1 year prior to screening * consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician (will be included in the list of allowed/disallowed medications) * pregnant or lactating or wish to become pregnant during the period of the study. * food allergies or intolerances * vegetarian (due to the standardized meals for appetite measurements) * unable to understand written and spoken swedish * lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or pi.
hypothalamic-pituitary effects after endoscopic third ventriculostomy

Conditions: Obstructive Hydrocephalus

Summary: background: endoscopic third ventriculostomy (etv) is a standard procedure for the treatment of obstructive hydrocephalus in children and adults. perforation of the third ventricle floor which is part of the hypothalamic-pituitary neuronal network is the key of this surgical procedure. purpose: there are no prospective data available about the endocrine effects after etv in children and adults. the principal aim of this prospective study is to evaluate the variability of hypothalamic-pituitary hormones and clinical effects in children and adults after etv in order to plan a multicentric study.

introduction endoscopic third ventriculostomy (etv) is a standard procedure for the treatment of obstructive hydrocephalus in children and adults. perforation of the third ventricle floor which is part of the hypothalamic-pituitary neuronal network is the key of this surgical procedure. single patients with endocrine or electrolyte abnormalities after etv have been reported in children or adults. so far there are no prospective data available about the endocrine effects after etv. materials and methods 40 patients (10 children, 30 adults) with obstructive hydrocephalus and inclusion criteria will undergo etv in our neurosurgical department. complete hypothalamic-pituitary hormonal evaluation will be done, in children and adults, before the procedure and at 3 and 12 month after etv. at 3 month, a brain mri, with hypothalamic-pituitary specifics sequences, will be performed and compared to the preoperative one. follow up will be at 3 and 12 month after etv. interventions: etv is performed under general anesthesia with a rigid endoscope. perforation is made just behind the clivus, halfway between the infundibulum and the mammillary bodies in the midline using a monopolar electrode, followed by dilatation with an inflated balloon catheter. in our department, this procedure is performed only by 2 senior surgeons. number of subjects: 40 patients: 10 children, 30 adults. statistical analysis: stratified analysis.

Eligibility criteria:
inclusion criteria: * all patients over 6 months old with obstructive hydrocephalus who are referred for planned endoscopic third ventriculocisternostomy exclusion criteria: * mri contraindication, non obstructive hydrocephalus, life expectancy inferior of 3 months, etv in emergency, hydrocephalus aetiology interaction with hypothalamic-pituitary hormones, hydrocephalus already treated, basilar artery malformations, to be allergic to tetracosactide (synacthene) and to benserazide (levodopa).

Keywords: hypothalamic pituitary, endoscopic third ventriculostomy hydrocephalus
a study to investigate the efficacy of padn to improved functional capacity and hemodynamics in patients with pah

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary arterial hypertension (pah) is characterized by premature death mainly because of progressive and severe right ventricular failure. target drugs are reported to be associated with significant improvement of clinical outcome for pah patients. however, previous studies using those target drugs focused on the change of 6-minute walk distance (6mwd) and or hemodynamic responses. as 6mwd has weak correlation with clinical outcome (time to clinical worsening, ttcw), benefits from target drugs for pah patients are not clear. we previously reported the safety and efficacy of pulmonary artery denervation (padn) for treatment of pah patients who were unresponsive to target drugs. hence, we design the randomized study to identify the effect of padn on pah.

the current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of padn on pah patients. based on the previous studies, the rate of pulmonary arterial hypertension (pah)-related event was around 30% after 6-month treatment using target drugs. and our previous data showed that this pah-related event at 6-month after padn procedure was 15%. as a result, a total of 270 pah patients was required, with 135 patients/per group at a ratio of 1:1 randomization. all patients underwent an 18f-dopa pet/ct scan of pulmonary arteries and the heart, performed at basement.

Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures; * men and women 18 years and older; * group i pah, defined as a mpap≥25mmhg, pcwp\ 3.0 woods unit. exclusion criteria: general exclusion criteria: * pregnancy and breast feeding mother; * estimated life expectancy \<12 months; * scheduled major surgery in the next 6 months; * inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; * previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days. procedural exclusion criteria: * who group ii, iii, iv, v ph * severe renal dysfunction (ccr\<30 ml/min) * blood platelet count\<100,000/l * expected life span\<6-month * systematical inflammation * malignant cancer(s) * tricuspid valve stenosis, supra-pulmonary valve stenosis * allergic to studied drugs or metal materials.

Keywords: pulmonary arterial hypertension
match-up: making telehealth-delivery of cancer care at home effective and safe-upscaled: a pragmatic cluster randomized trial

Conditions: Breast Cancer; Prostate Cancer

Summary: many people with cancer spend a lot of time and money traveling to and from the doctor's office for cancer care. msk's goal is to make getting cancer care easier by cutting down the need to make in-person visits to msk. msk is trying to do this through a new option called enhanced telehealth.


Eligibility criteria:
inclusion criteria: * patients with breast or prostate cancer at memorial sloan kettering cancer center who have had at least 3 prior medical oncology visits. exclusion criteria: * patient is enrolled on a therapeutic clinical trial. * patients whose primary language is not currently supported by epic.

Keywords: telehealth cancer care at home
improving patient outcome in group therapy for eating disorders

Conditions: Bulimia Nervosa (BN); Binge Eating Disorder (BED); Eating Disorder Not Otherwise Specified (EDNOS)

Summary: the current trial aims to investigate the impact of continuous feedback on dropout and outcome in group therapy. the hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1) increase adherence and 2) increase treatment outcome.

background: in the psychotherapy of eating disorders, a dropout rate between 30% and 50% is reported internationally. the fact that up to half of the patients drop out of treatment calls for ways to improve it. research shows that feedback to patient and therapist increases outcome and reduces the number of dropouts; however there is only three published works on the effect of feedback in eating disorders treatment. therefore, the present trial, at the eating disorders unit at stolpegaard psychotherapy centre, gentofte, denmark, may contribute to necessary improvements in the field. objective: the current trial, which will be conducted from august 2012 to august 2014, aims to investigate the impact of continuous feedback on adherence and outcome in group psychotherapy. the hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1)increase adherence 2) increase treatment outcome. method: the trial is set up in a randomized design with 159 patients allocated to a) treatment with feedback intervention or b) treatment as usual. participants: the participants are diagnosed with bulimia nervosa, binge eating disorder or eating disorder not otherwise specified. interventions: in the experimental group, two sets of feedback measures are added to the standard treatment: outcome rating scale (ors) and group session rating scale (gsrs). the ors assesses areas of life functioning known to change as a result of therapeutic intervention. the gsrs assesses key dimensions of effective therapeutic relationships.

Eligibility criteria:
inclusion criteria: * aged 18 or older. * bmi of minimum 20. * meet the diagnostic criteria for bulimia nervosa, binge eating disorder or ednos according to dsm- iv. exclusion criteria: * acute suicidal risk. * psychosis. * severe depression. * abuse of alcohol, medicine and/or narcotics up to 3 months before referral. * use of cannabis once a month is accepted at intake but must stop during treatment. * concomitant psychotherapeutic/ psychiatric treatment outside stolpegaard psychotherapy centre. * severe or non-regulated physical co-morbidity. * pregnancy. * unable to understand danish. * previous participation in the current trial. * considered unable to attend treatment sessions as planned. * lack of informed consent.
olfactory function and olfactory bulb volume in acromegaly patients

Conditions: Acromegaly; Olfactory Disorder

Summary: a prospective, controlled, single blinded study was planned. 20 patients with acromegaly (acromegaly group) and 20 healthy subjects (control group) were planned to include in the study. connecticut chemosensory clinical research center (cccrc) test was applied to evaluate olfactory functions. olfactory bulb(ob) volumes were measured with a 1.5 t general electric signa excite mri scanner.

acromegaly patients were assessed at the endocrinology department for their clinical symptoms, and the nasal examination and olfactory evaluation were done at the department of otorhinolaryngology. ob volume was evaluated by a single blinded radiologist. control group patients that had similar demographical characteristics with the acromegaly group were recruited in the study. the cccrc test is composed of n-butanol odor threshold test and odor identification test. olfactory tests were scored out of 7 (0: worst, 7: best olfaction) and mean score was calculated as the total cccrc test score. ob measurements were done individually on the right and left olfactory bulbs and the mean ob volume was calculated in cubic millimeters.

Eligibility criteria:
inclusion criteria: * acromegaly diagnosis * healthy subjects that had no nasal problems exclusion criteria: * previous nasal surgery * acute respiratory tract infection * nasal polyposis * nasal pathologies that causes nasal obstruction

Keywords: acromegaly olfaction olfactory disorder
interactive decision aid for men diagnosed with prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer is the second leading cause of cancer related deaths in the western world (national cancer institute, 2011). prostate cancer diagnosis relates to significant psychological distress (roesch et al, 2005; hervouet et al, 2005). the management options available for men with localized prostate cancer typically offer similar survival rate and one treatment has not been determined more effective than other. variance in severity, duration and frequency of side effects between treatments is considerable (national cancer institute, 2011). this can make the choice between management options challenging and distressing. researches show that patients that are actively involved and provided with sufficient information have better health outcomes (stewart, 1995). the study involves implementing interactive, web-based decision-aid to assist men with localized prostate cancer with their decision regarding their prostate cancer management options. participants will be randomized to standard-care (sc) and sc + interactive decision-aid (ida). the sc group will meet with their urologist and receive and information brochure. in addition the ida group will receive a website that includes a wealth of information (e.g., overview about prostate cancer, overview of different treatment options, pros and cons of different treatment options and a value clarification exercise that is designed to assist participants to weigh the risks and benefits of each prostate cancer management option). the effectiveness of the intervention will be evaluated with questionnaires administered prior to randomization (baseline) and then again two weeks, one, three and six months after the randomization. aim 1. evaluate the relative impact of sc versus sc + ida on medical decision making. it is hypothesized that participants randomized to the sc + ida arms will have improved decision making (e.g., reduced decisional conflict) and psychosocial outcomes (e.g., distress), compared to those randomized to sc only. aim 2. identify mechanisms by which the interventions impact patient outcomes. it is hypothesized that: 1) improved decision making and psychosocial outcomes for the ida arms will be mediated by increased knowledge; 2) participants who are undecided about the treatment decision and those that have information-seeking decision styles will benefit most from the decision-aid interventions.


Eligibility criteria:
inclusion criteria: * newly diagnosed with localized prostate cancer. exclusion criteria: * reads and understands icelandic * can give informed consent

Keywords: localized prostate cancer decision aid medical decision making